Peripheral intravenous catheters having flow diverting features

ABSTRACT

PIVCs with extension sets can include one or more flow diverting features for maximizing the amount of flushing that occurs within the interior of the catheter adapter. These flow diverting features can therefore minimize the amount of residual blood, medicament, or other fluid that may exist within the catheter adapter after the PIVC has been flushed via the extension set. The flow diverting features may be in the form of structural modifications to the side port of the extension set, separate components that are contained within the side port or catheter adapter, integrated components within the side port or catheter adapter, other features or some combination of any of these features.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/716,812, filed Sep. 27, 2017, and entitled PERIPHERAL INTRAVENOUSCATHETERS HAVING FLOW DIVERTING FEATURES, which is incorporated hereinin its entirety.

BACKGROUND

A peripheral intravenous catheter (PIVC) is an intravenous device thatis designed to be placed into a peripheral vein. A PIVC may oftentimesbe configured as a “closed” or “integrated” IV device which refers tothe fact that the device is configured to prevent blood from escapingthe device during insertion of the catheter. Typically, such PIVCs aredesigned with an integrated extension set to accomplish this.

FIG. 1 provides an example of a typical PIVC 100 that includes anintegrated extension set. PIVC 100 includes a catheter adapter 101having a distal end from which a catheter 102 extends and a proximal endwithin which a septum 103 is positioned. Although not shown, PIVC 100would initially include an insertion needle that would extend from theproximal end of catheter adapter 101, through septum 103, and outthrough the distal end of catheter 102. Septum 103 functions to seal theinterior of catheter adapter 101 after this insertion needle (or anyother inserted device) is withdrawn. The extension set of PIVC 100 isformed by a side port 104 which is fluidly coupled to the interior ofcatheter adapter 101, an extension tube 105, and an adapter 106. Fluidinjected into extension tube 105 via adapter 106 will flow into theinterior of catheter adapter 101 via side port 104 and ultimately intothe patient via catheter 102. In this way, a fluid, such as amedicament, can be administered to the patient without requiring directaccess to the interior of catheter adapter 101.

While a PIVC is inserted into a patient's vein, it may be necessary toflush the PIVC. For example, during the insertion of catheter 102, bloodmay flow proximally through catheter 102 and into the interior ofcatheter adapter 101. It is typically desirable to flush the blood fromcatheter adapter 101 to prevent the growth of bacteria or otherpathogens. On the other hand, when a medicament is administered throughthe extension set, some of the medicament will likely remain withincatheter adapter 101. Again, it is typically desirable to flush anyresidual medicament from catheter adapter 101 into the patient. Thisflushing is typically accomplished by injecting saline into catheteradapter 101 via the extension set.

With existing PIVCs, it is difficult to completely flush catheteradapter 101 by injecting saline through the extension set. For example,due to the angle of side port 104 relative to the longitudinal axis ofcatheter adapter 101, the saline will flow into catheter adapter 101 ina distal direction towards catheter 102. To accommodate septum 103, theinterior of catheter adapter 101 may be elongated in a proximaldirection relative to the opening of side port 104. Although there willbe some diversion, the primary flow of the saline will be directlybetween the opening of side port 104 and catheter 102 as represented bythe arrows in FIG. 1A. As a result, it is likely that residual blood,medicament, or other fluid that is located in this “proximal elongatedregion” will not be adequately flushed from catheter adapter 101.

BRIEF SUMMARY OF THE INVENTION

The present invention is generally directed to PIVCs with extension setswhere the PIVCs include one or more flow diverting features formaximizing the amount of flushing that occurs within the interior of thecatheter adapter. These flow diverting features can therefore minimizethe amount of residual blood, medicament, or other fluid that may existwithin the catheter adapter after the PIVC has been flushed via theextension set. The flow diverting features may be in the form ofstructural modifications to the side port of the extension set, separatecomponents that are contained within the side port or catheter adapter,integrated components within the side port or catheter adapter, or otherfeatures.

In one embodiment, the present invention is implemented as an IV accessdevice that includes: a catheter adapter having a proximal end and adistal end and a sidewall forming a lumen that extends therebetween; acatheter that extends from the distal end; a side port that extendsoutwardly from the sidewall of the catheter adapter, the side port beingin fluid communication with the lumen of the catheter adapter; and aflow diverting feature configured to divert fluid flowing through theside port and into the lumen in a proximal direction. In some cases, theflow diverting feature may be in the form of at least one of aprotrusion from a sidewall of the side port; a diverter that ispositioned centrally within an opening of the side port to thereby forma distal channel and a proximal channel around the diverter for fluidflowing from the side port and into the lumen; a protrusion from aportion of the sidewall of the catheter adapter, the portion of thesidewall being positioned opposite the side port; an insert; or acombination of such features.

In another embodiment, the present invention is implemented as aperipheral intravenous catheter that includes: a catheter adapter havinga proximal end and a distal end and a sidewall forming a lumen thatextends therebetween; a catheter that extends from the distal end; aside port that extends outwardly from the sidewall of the catheteradapter, the side port being in fluid communication with the lumen ofthe catheter adapter; and a flow diverting feature configured to divertfluid flowing through the side port and into the lumen in a proximaldirection. In some cases, the flow diverting feature may comprise one ormore of: a protrusion from a sidewall of the side port; a diverter thatis positioned centrally within an opening of the side port to therebyform a distal channel and a proximal channel around the diverter forfluid flowing from the side port and into the lumen; a protrusion from aportion of the sidewall of the catheter adapter, the portion of thesidewall being positioned opposite the side port; or an insert that ispositioned within the lumen or within the side port.

In another embodiment, the present invention is implemented as an IVaccess device that includes: a catheter adapter having a proximal endand a distal end and a sidewall forming a lumen that extendstherebetween; a catheter that extends from the distal end; a septumpositioned within the lumen at the proximal end of the catheter adapter;a side port that extends outwardly from the sidewall of the catheteradapter, the side port being in fluid communication with the lumen ofthe catheter adapter; and one or more flow diverting features comprisingone or more of: a protrusion from a sidewall of the side port; adiverter that is positioned centrally within an opening of the side portto thereby form a distal channel and a proximal channel around thediverter for fluid flowing from the side port and into the lumen; aprotrusion from a portion of the sidewall of the catheter adapter, theportion of the sidewall being positioned opposite the side port; or aninsert that is positioned within the lumen or within the side port.

These and other features and advantages of the present invention may beincorporated into certain embodiments of the invention and will becomemore fully apparent from the following description and appended claims,or may be learned by the practice of the invention as set forthhereinafter. The present invention does not require that all theadvantageous features and all the advantages described herein beincorporated into every embodiment of the invention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In order that the manner in which the above-recited and other featuresand advantages of the invention are obtained will be readily understood,a more particular description of the invention briefly described abovewill be rendered by reference to specific embodiments thereof that areillustrated in the appended drawings. These drawings depict only typicalembodiments of the invention and are not therefore to be considered tolimit the scope of the invention.

FIG. 1 illustrates a prior art PIVC that includes an extension set;

FIG. 1A illustrates how an area of reduced flushing may exist withinprior art PIVCs;

FIG. 2 illustrates a PIVC that includes a flow diverting feature that isintegrated into the side port of an extension set;

FIG. 2A illustrates how the flow diverting feature of FIG. 2 enhancesthe flushing of the catheter adapter;

FIG. 2B illustrates a curved embodiment of the flow diverting feature ofFIG. 2;

FIG. 2C illustrates how a flow diverting feature can be integrated intothe center of the side port;

FIG. 3A illustrates a PIVC that includes a side port that has a centralaxis that is offset relative to the central axis of the catheteradapter;

FIG. 3B illustrates a PIVC that includes a side port that has a centralaxis parallel to but spaced apart from the central axis of the catheteradapter;

FIG. 4 illustrates a PIVC that includes a flow diverting feature that ispositioned on a sidewall of the catheter adapter opposite the side portof the extension set;

FIG. 5A illustrates a PIVC that includes a flow diverting insert that ispositioned within the catheter adapter;

FIG. 5B illustrates a PIVC that includes a flow diverting insert that ispositioned within the side port;

FIGS. 6A and 6B each illustrate a PIVC that includes a side port that ispositioned proximate to a septum housed within a proximal end of thecatheter adapter;

FIG. 7 illustrates a PIVC that includes a flow diverting insert that ispositioned within the catheter adapter distal to the side port; and

FIG. 7A illustrates a detailed perspective view of the flow divertinginsert shown in FIG. 7.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 2 illustrates a cross-sectional view of a PIVC 200 that can beconfigured to include one or more flow diverting features in accordancewith embodiments of the present invention. Similar to PIVC 100, PIVC 200includes a catheter adapter 201, a catheter 202 that extends from adistal end of catheter adapter 201, a septum 203 that is positionedwithin a proximal end of catheter adapter 201, a side port 204 thatextends from a sidewall of catheter adapter 201 and provides a fluidpathway into an interior of catheter adapter 201, and an extension tube205 that is coupled to side port 204. Although the general structure ofPIVC 200 is shown as being similar to the general structure of PIVC 100,this need not be the case. The flow diverting features of the presentinvention can be incorporated into many different configurations/designsof PIVCs with extension sets.

In FIG. 2, PIVC 200 is configured with a flow diverting feature in theform of a protrusion 210 from the sidewall of side port 204. Protrusion210 extends into the path of fluid that flows into catheter adapter 201from the extension set. Two primary characteristics of protrusion 210are provided in FIG. 2: (1) an angle of the face 210 a of protrusion 210relative to the sidewall of side port 204; and (2) a height ofprotrusion 210. In the embodiment shown in FIG. 2, the angle of face 210a is 85° which implies that face 210 a will be nearly perpendicular tothe primary direction of fluid flow into catheter adapter 201. Theheight of protrusion 201 as depicted is 0.016 inches (0.4064 mm). Thisheight is measured as the distance between the tip of face 210 a and thepoint where the axis of the sidewall of side port 204 intersects thesidewall of catheter adapter 201 (i.e., the point where the opening ofside port 204 would have started if the side wall did not includeprotrusion 210). This height therefore defines how far protrusion 210extends proximally into the opening of side port 204 along the axis ofthe sidewall of catheter adapter 201.

Variations in the angle and/or height of protrusion 210 can be made toaccomplish different levels of flushing with different impacts on thepressure of the flushing fluid. For example, based on simulations, whenprotrusion 210 has the depicted angle and height, a 57% in flushingefficiency may be obtained relative to PIVC 100 with an increase inpressure of only 0.2 psi. Other variations that have proven to increasethe flushing efficiency include a height of 0.012 inches (0.3048 mm) andan angle of 85°, a height of 0.020 inches (0.508 mm) and an angle of85°, and a height of 0.016 inches (0.4064 mm) and an angle of 60°. Thesevariations are provided as examples only and should not be construed aslimiting the invention to any particular dimensions.

FIG. 2A generally illustrates how protrusion 210 can increase theflushing efficiency of PIVC 200. As represented by the arrows, fluidflowing through side port 204 and into catheter adapter 201 will bediverted by protrusion 210 to create an eddy towards the proximal end ofcatheter adapter 201. This eddy will minimize the amount of blood,medicament, or other fluid that may remain at the proximal end ofcatheter adapter 201 after flushing. As mentioned above, this can beaccomplished with a relatively trivial increase in the pressure of theflushing fluid (i.e., a trivial increase in force will be required toflush PIVC 200).

Protrusion 210 can be formed in any suitable way. For example, a moldthat is used to produce catheter adapter 201 and side port 204 could bemodified to form protrusion 210. Alternatively, protrusion 210 could beformed as a separate component that is coupled to side port 204 in anysuitable manner. In cases where it is formed as a separate component,protrusion 210 can be formed of a material that is designed to applyantimicrobial benefits to the fluid contained within catheter adapter201 as will be further described below.

FIG. 2B illustrates an embodiment where protrusion 210 has a curved face210 a. In some embodiments, configuring face 210 a to be curved hasresulted in a reduction in the pressure of the flushing fluid and hasprovided a slight increase in the flushing efficiency. A curved face 210a can be employed on any of the above-described variations of protrusion210 as well as on any other reasonable variation. Although not shown, insome embodiments, face 210 a can be curved in a spiraling manner. Thisspiraling can be accomplished by varying the height of protrusion 210along the various cross-sections. This variation in the height willcause the fluid to be redirected at slightly different angles along thedepth of protrusion 210 which in turn can impart a spiraling pattern tothe resulting eddy.

FIG. 2C illustrates an embodiment where a diverter 220, which has thesame general cross-sectional shape as protrusion 210, is positionedcentrally within the opening of side port 204. Although not visible inFIG. 2C, diverter 220 could extend between the “upper” and “lower”sidewalls of side port 204 to thereby form fluid channels along theproximal and distal sides of side port 204. As with protrusion 210,diverter 220 has a height and includes a face 220 a with an angle. Boththe height and angle of diverter 220 can be similar to the variationsdescribed above for protrusion 210. Simulations have shown that diverter220 can further improve the flushing efficiencies beyond those obtainedwith protrusion 210 albeit with an increase in the flushing pressure.

FIGS. 3A and 3B each illustrate an embodiment of a PIVC 300 that canhave a similar overall structure as the previously described PIVCs. Forexample, PIVC 300 is shown as including a catheter adapter 301, acatheter 302, a septum (not shown), a side port 304, and an extensiontube 305. Unlike the previous figures, FIGS. 3A and 3B arecross-sectional views taken perpendicular to the longitudinal axis ofcatheter adapter 301 and through side port 304.

In contrast to PIVC 200 where the longitudinal axis of side port 204 wasassumed to be in the same plane as the longitudinal axis of catheteradapter 201, the longitudinal axis of side port 304 is either offsetrelative to the plane of the longitudinal axis of catheter adapter 301(FIG. 3A) or is parallel to but spaced apart from this plane (FIG. 3B).

More particularly, in FIG. 3A, although the opening of side port 304 isintersected by the plane of the central axis of catheter adapter 301,the central axis of side port 304 is angled downwardly (or upwardlydepending on the orientation of the PIVC) relative to this plane (asrepresented by the less-than 180° angle between the two axes). As aresult, fluid flowing into catheter adapter 301 via side port 304 willenter catheter adapter 301 at an angle that deviates from the centralaxis and will thereby cause the fluid to flow in a swirling or spiralingmanner within catheter adapter 301 to increase the flushing efficiency.

A similar swirling or spiraling flow of the flushing fluid can beachieved by configuring side port 304 so that its central axis issubstantially parallel with but spaced from the central axis of catheteradapter 301 (by some non-inconsequential distance x) as shown in FIG.3B. In this way, the opening of side port 304 will be offset towards abottom (or top depending on the orientation of the PIVC) of catheteradapter 301.

In both embodiments of PIVC 300, the flow of flushing fluid as it exitsside port 304 will be directed towards a portion of the sidewall ofcatheter adapter 301 that is below the central axis. The generallycircular shape of catheter adapter 301 will then cause flow to bediverted upwardly in a curving and spiraling manner which will minimizethe amount of residual blood, medicament, or other fluid after flushing.In some embodiments, a side port of a PIVC could be configured inaccordance with both FIGS. 3A and 3B (i.e., the side port could beangled relative to and offset from the central axis of catheter adapter301).

FIG. 4 illustrates an embodiment of a PIVC 400 where a flow divertingfeature is formed along a sidewall of the catheter adapter opposite theside port. As shown, PIVC 400 includes a catheter adapter 401, acatheter 402, a septum 403, a side port 404, and an extension tube 405and therefore has a similar general structure as the previouslydescribed PIVCs. Additionally, PIVC 400 includes a flow divertingfeature in the form of a protrusion 410 from the sidewall of catheteradapter 401. Protrusion 410 can be positioned opposite side port 404 sothat fluid flowing out from side port 404 will be incident on protrusion410. Protrusion 410 can include a proximally directed face 410 a and adistally directed face 410 b. Face 410 a can cause fluid to be divertedin a proximal direction to thereby create an eddy towards the proximalend of catheter adapter 401.

FIGS. 5A and 5B each illustrate an embodiment of a PIVC 500 thatincludes a flow diverting feature in the form of an insert. PIVC 500includes a catheter adapter 501, a catheter 502, a septum 503, a sideport 504, and an extension tube 505. As can be seen, the structure ofPIVC 500 itself can be the same as PIVC 100 or any other PIVC thatincludes an extension set.

In FIG. 5A, PIVC 500 includes an insert 510 a that is positioned withincatheter adapter 501 overtop the opening of side port 504. Insert 510 acan include a number of openings forming channels through the insertincluding at least one channel that diverts flow of the flushing fluidin a proximal direction. A suitable insert can be configured with manydifferent shapes, sizes, and orientations of openings to accomplish thisdiversion.

In FIG. 5B, PIVC 500 includes an insert 510 b that is positioned insideside port 504 and may extend partially into catheter adapter 501. Aswith insert 510 a, insert 510 b can include a number of openings formingchannels for diverting flow of the flushing fluid in a proximaldirection. The diversion of flow in the proximal direction can create aneddy to enhance the flushing efficiency as described above.

FIGS. 6A and 6B each illustrate how the relative position of the sideport along the longitudinal axis of the catheter adapter can be adjustedto further enhance flushing efficiency. Each of these figures depicts aPIVC 600 having a catheter adapter 601, a catheter 602, a septum 603, aside port 604 and an extension tube 605. In FIG. 6A, side port 604 ispositioned in a more proximal location proximate septum 603. Bypositioning side port 604 immediate to septum 603, the area withincatheter adapter 601 that is proximal to side port 604 is minimized. Byminimizing this area, the eddy and/or proximal diversions provided bythe previously described flow diverting features may be more effective.In FIG. 6B, side port 604 is further shown as being oriented at agreater angle relative to catheter adapter 601. In this case, the angleis acute but nearly 90°. With this near 90° angle, the amount by whichthe flushing fluid will need to be diverted to enhance flushingefficiency is reduced. This is especially true when side port 604 isalso positioned proximate to septum 603 as shown in FIG. 6B.

Repositioning of side port 604 to be more proximate to septum 603 and/oradjusting of the angle of side port 604 to be closer to 90° can beperformed in conjunction with any of the previously described flowdiverting features to enhance their effectiveness. For example, PIVC 600could also include protrusion 210 or protrusion 410 to cause an eddy tobe formed in the proximal end of catheter adapter 601. Due to thelimited area of this proximal end, the formation of the eddy duringflushing can result in significant improvements in flushing efficiencythan were possible in prior art PIVCs. The same would be true byincluding insert 510 a or 510 b in PIVC 600 or by further configuringside port 604 in accordance with FIGS. 3A or 3B.

FIG. 7 illustrates a PIVC 700 having a catheter adapter 701, a catheter702, a septum 703, a side port 704 and an extension tube 705. PIVC 700also includes a flow diverting feature in the form of an insert 710 thatis positioned distal to side port 704. As shown, insert 701 can have agenerally annular shape (see FIG. 7A) and can be configured to fitsnuggly within the sidewalls of catheter adapter 701 (e.g., via acompression fit). Insert 710 can include a proximal face 710 a that isoriented outwardly and that extends proximally overtop the opening ofside port 704. Face 710 a can therefore function in a similar manner asprotrusion 210 to divert flow of the flushing fluid in a proximaldirection.

In some embodiments, inserts 510 and 710 can be formed of a materialthat provides antimicrobial benefits within the catheter adapter. Forexample, inserts 510 or 710 could be formed of or coated with a materialthat elutes an antimicrobial agent such as chlorhexidine. In someembodiments, these inserts could be formed primarily of a hydroscopicmaterial that will swell when wetted to prevent dislodgment.

Although the various flow diverting features have been primarilydescribed as being implemented separately on a PIVC, a combination oftwo or more of the described features could be employed on a singlePIVC. Also, the described flow diverting features can be employed on anytype or configuration of a PIVC that includes an extension set (i.e., onany PIVC that has a side port that is used for flushing). Further,although the description has been limited to PIVCs, the flow divertingfeatures can be employed on any other IV access device that includes aside port.

The present invention may be embodied in other specific forms withoutdeparting from its structures, methods, or other essentialcharacteristics as broadly described herein and claimed hereinafter. Thedescribed embodiments are to be considered in all respects only asillustrative, and not restrictive. The scope of the invention is,therefore, indicated by the appended claims, rather than by theforegoing description. All changes that come within the meaning andrange of equivalency of the claims are to be embraced within theirscope.

1. An IV access device comprising: a catheter adapter having a proximalend and a distal end and a sidewall forming a lumen that extendstherebetween; a catheter that extends from the distal end; a side portthat extends outwardly from the sidewall of the catheter adapter, theside port being in fluid communication with the lumen of the catheteradapter; and a flow diverting feature configured to divert fluid flowingthrough the side port and into the lumen in a proximal direction,wherein the flow diverting feature comprises a diverter that ispositioned centrally within an opening of the side port to thereby forma distal channel and a proximal channel around the diverter for fluidflowing from the side port and into the lumen.
 2. The IV access deviceof claim 1, wherein the diverter extends between opposing sides of theside port.
 3. A peripheral intravenous catheter comprising: a catheteradapter having a proximal end and a distal end and a sidewall forming alumen that extends therebetween; a catheter that extends from the distalend; a side port that extends outwardly from the sidewall of thecatheter adapter, the side port being in fluid communication with thelumen of the catheter adapter; and a flow diverting feature configuredto divert fluid flowing through the side port and into the lumen in aproximal direction.
 4. The peripheral intravenous catheter of claim 3,wherein: a longitudinal axis of the side port is offset relative to aplane of a longitudinal axis of the catheter adapter such that fluidflowing from the side port and into the lumen is directed at an anglethat diverges from the plane; or a longitudinal axis of the side port issubstantially parallel to but offset from a plane of a longitudinal axisof the catheter adapter.
 5. An IV access device comprising: a catheteradapter having a proximal end and a distal end and a sidewall forming alumen that extends therebetween; a catheter that extends from the distalend; a septum positioned within the lumen at the proximal end of thecatheter adapter; a side port that extends outwardly from the sidewallof the catheter adapter, the side port being in fluid communication withthe lumen of the catheter adapter; and one or more flow divertingfeatures comprising; a diverter that is positioned centrally within anopening of the side port to thereby form a distal channel and a proximalchannel around the diverter for fluid flowing from the side port andinto the lumen.